Micron Technologies’ Quality Control Lab supports
operations with numerous state of the art analytical techniques located on site
to provide "real time" data. This allows decisions to be made during
processing, saving valuable time, assuring quality of the drug substance and
maintaining project timelines.
We offer Particle Size Analysis, which is probably one of
the most important techniques and is conducted using laser diffraction
(Malvern or Sympatec) systems. We also offer Wet and Dry analysis with
histograms for each sample analyzed, Method Development and Validation
which is recommended once a product reaches phase 2 in the clinic, and
microscopy to assess the compound before and after the micronization process.
Microscopy is also used for troubleshooting in support of particle size.
All materials entering our plants will undergo
identification testing via FTIR and is subjected to cleaning recovery studies to
comply with the 100% cleaning verification program.
Other techniques available upon request:
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Differential Scanning Calorimeter (DSC)
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Surface Area Analysis by BET
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X-ray Powder Diffraction (XRPD)
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HPLC & GC
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